SP Thoracic IDE Study (NCT05150210) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SP Thoracic IDE Study
United States32 participantsStarted 2022-07-20
Plain-language summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 21 years
* BMI ≤ 35
* ASA ≤ 3
* Willing and able to provide a written informed consent
* Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years
Lobectomy Inclusion Criteria:
\- Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter
Thymectomy Inclusion Criteria:
\- Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter
Exclusion Criteria:
* Clinical or radiological evidence of mediastinal or systemic metastatic disease
* Life expectancy \< 6 months
* Subject with a known bleeding or clotting disorder
* Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation
* Uncontrolled systemic illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Previous chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected
* Subject has a contraindication for general anesthesia or surgery
* Subjects under active immunomodulatory or immunosup…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Conversion
Timeframe: Intra-operative period
2
Major Adverse Event Rate
Timeframe: Intra-operative through the 30 days follow-up period